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FDA ANDA · ANDA086173

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: FOSUN PHARMA

APPLICATION
ANDA086173
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-28
LATEST ACTION
2000-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDiscontinued
ATROPINE SULFATE 0.025MG, DIPHENOXYLATE HYDROCHLORIDE 2.5MG · TABLET · ORAL

Approval history

2000-11-28Manufacturing (CMC) · Supplement 11AP
2000-04-03Manufacturing (CMC) · Supplement 10AP
1999-04-06Labeling · Supplement 9AP
1988-07-26Bioequivalence · Supplement 8AP
1983-05-16Manufacturing (CMC) · Supplement 1AP
1983-05-16Manufacturing (CMC) · Supplement 2AP
1981-08-28OriginalAP
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Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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